Long Term Safety and Efficacy Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02125279
• Collaborator: (none)
• Enrollment: 54
• Locations: 16
• Arm: 1
• Actual Duration (Months): 48
• Patients Per Site: 3.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the safety and efficacy of up to 26 weeks of treatment with calcitriol 3 mcg/g ointment when used twice daily, without occlusion, to treat pediatric subjects (2 to 16 years and 11 months of age) with mild to moderate plaque psoriasis.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Vulgaris	Drug: Calcitriol	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter Open Label Uncontrolled Study of the Long Term Safety and Efficacy of Calcitriol 3 mcg/g Ointment Applied Twice Daily for 26 Weeks in Pediatric Subjects (2 to 16 Years and 11 mo of Age) With Mild to Moderate Plaque Psoriasis
• Actual Study Start Date: May 1, 2014
• Actual Primary Completion Date: May 1, 2018
• Actual Study Completion Date: May 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Calcitriol ointment	Drug: Calcitriol

Outcome Measures

Primary Outcome Measures

1. Change From Screening in Serum Albumin Levels at Week 4 [Screening, Week 4]

   Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 4 were reported.

2. Change From Screening in Serum Albumin Levels at Week 8 [Screening, Week 8]

   Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 8 were reported.

3. Change From Screening in Serum Albumin Levels at Week 12 [Screening, Week 12]

   Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 12 were reported.

4. Change From Screening in Serum Albumin Levels at Week 20 [Screening, Week 20]

   Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 20 were reported.

5. Change From Screening in Serum Albumin Levels at Week 26 [Screening, Week 26]

   Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 26 were reported.

6. Change From Screening in Serum Albumin Levels at Week 30 (Follow-up) [Screening, Week 30 (Follow-up)]

   Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 30 were reported.

7. Change From Screening in Urine Calcium/Creatinine Ratio at Week 12 [Screening, Week 12]

   Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 12 were reported.

8. Change From Screening in Urine Calcium/Creatinine Ratio at Week 26 [Screening, Week 26]

   Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 26 were reported.

9. Change From Screening in Urine Calcium/Creatinine Ratio at Week 30 (Follow-up) [Screening, Week 30 (Follow-up)]

   Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 30 were reported.

10. Change From Screening in Serum Phosphate Levels at Week 4 [Screening, Week 4]

    Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 4 were reported.

11. Change From Screening in Serum Phosphate Levels at Week 12 [Screening, Week 12]

    Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 12 were reported.

12. Change From Screening in Serum Phosphate Levels at Week 20 [Screening, Week 20]

    Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 20 were reported.

13. Change From Screening in Serum Phosphate Levels at Week 26 [Screening, Week 26]

    Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 26 were reported.

14. Change From Screening in Serum Phosphate Levels at Week 30 (Follow-up) [Screening, Week 30 (Follow-up)]

    Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 30 were reported.

15. Change From Screening in Serum Parathyroid Hormone (PTH) Levels at Week 4 [Screening, Week 4]

    Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 4 were reported.

16. Change From Screening in Serum Parathyroid Hormone Levels at Week 8 [Screening, Week 8]

    Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 8 were reported.

17. Change From Screening in Serum Parathyroid Hormone Levels at Week 12 [Screening, Week 12]

    Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 12 were reported.

18. Change From Screening in Serum Parathyroid Hormone Levels at Week 20 [Screening, Week 20]

    Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 20 were reported.

19. Change From Screening in Serum Parathyroid Hormone Levels at Week 26 [Screening, Week 26]

    Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 26 were reported.

20. Change From Screening in Serum Parathyroid Hormone Levels at Week 30 (Follow-up) [Screening, Week 30 (Follow-up)]

    Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 30 were reported.

21. Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Up to Week 30]

    An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with an onset date on or after the first application of the study drug.

Secondary Outcome Measures

1. Number of Participants With Investigator's Global Assessment of Disease Severity (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Each Visit [Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)]

   The IGA is a 0 to 4 point scale. Where, 0 = clear (no signs of psoriasis except for residual hypopigmentation/hyperpigmentation); 1 = almost clear (just perceptible erythema, no induration, and no scaling); 2 = mild (mild erythema, no induration, and mild or no scaling); 3 = moderate (moderate erythema, mild induration, and mild or no scaling); 4 = severe (severe erythema, moderate to severe induration, and scaling of any degree).

2. Change From Baseline in Pruritus Score at Each Visit [Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)]

   Pruritus was scored on a 0 to 4 point scale. Where, 0 = none (no-itching); 1 = mild (slight itching, not really bothersome); 2 = moderate (definite itching that is somewhat bothersome without loss of sleep); 3 = severe (intense itching that has caused pronounced discomfort, night rest interrupted); 4 = very severe (very severe itching that has caused pronounced discomfort during the night and daily activities). Positive change from baseline indicate worsening of indication.

3. Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit [Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)]

   Percent BSA was calculated by modified rules of nines (pediatric participants). Estimate were made from the following for a child up to the age of one year: head and neck total for front and back - 18%; thorax and abdomen-front -18%; thorax and abdomen-back - 18%; each upper limb total for front and back - 9%; each lower limb total for front and back - 14%. For over the age of one year, the relative percentage of BSA changes as follows: the head decreases by 1% per year and the lower limbs increase by 0.5% per year. By the age of ten years, the relative proportions assume the values for adult BSA as follows: perineum becomes 1%; each lower limb becomes a total of 18% front and back; head and neck become 9% total for front and back.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female 2 to 16 years and 11 months of age

• Clinical diagnosis of stable mild to moderate plaque psoriasis

Exclusion Criteria:

• Other forms of psoriasis

• Hypercalcemia

• Past history of kidney stones

• Vitamin D deficiency

• Other concomitant dermatological disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johnson Dermatology	Fort Smith	Arkansas	United States	72916
2	Northwest Arkansas Clinical Trials Center, PLLC	Rogers	Arkansas	United States	72758
3	Advanced Skincare Surgery & Medcenter	Burbank	California	United States	91505
4	University of South Florida	Tampa	Florida	United States	33612
5	Shideler Clinical Research Center	Carmel	Indiana	United States	46032
6	Dawes Fretzin Clinical Research Group	Indianapolis	Indiana	United States	46256
7	Montefiore Medical Center	New York	New York	United States	10467
8	Arlington Research Center for Dermatology	Arlington	Texas	United States	76011
9	UZ Gent Dermatology Department	Gent		Belgium	9000
10	Lynderm Research Inc.	Markham	Ontario	Canada	L3P1X2
11	CHU Sainte-Justine	Montreal	Quebec	Canada	H3T1C5
12	Charité Universitätsmedizin Berlin	Berlin		Germany	10117
13	University Hospital Carl Gustav Carus	Dresden		Germany	01307
14	Universitäts-Hautklinik Mainz, Johannes Gutenberg-Universität Mainz	Mainz		Germany	55131
15	Padova University Hospital	Padova		Italy	35128
16	University of Parma	Parma		Italy	43126

Sponsors and Collaborators

• Galderma R&D

Investigators

• Study Director: Michael Graeber, MD, Galderma R&D, LLC

Study Documents (Full-Text)

• Study Protocol - Jan 7, 2016
• Statistical Analysis Plan - May 27, 2014

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT02125279
• Other Study ID Numbers: RD.06.SPR.18131
• First Posted: Apr 29, 2014
• Last Update Posted: Feb 18, 2021
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Psoriasis; Calcitriol

Study Results

Participant Flow

Pre-assignment Detail	A total of 88 participants were screened. Only 54 participants out of 88 were enrolled and received study drug, of which 41 participants completed the study.

Arm/Group Title	Calcitriol 3 mcg/g
Arm/Group Description	Participants received calcitriol 3 microgram per gram (mcg/g) ointment applied twice daily without exceeding a maximum of 0.5 gram per kilogram (g/kg) of body weight or 28 gram (g) daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
Period Title: Overall Study
STARTED	54
COMPLETED	41
NOT COMPLETED	13

Baseline Characteristics

Arm/Group Title	Calcitriol 3 mcg/g
Arm/Group Description	Participants received calcitriol 3 mcg/g ointment applied twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
Overall Participants	54
Age (Count of Participants)
<=18 years	54 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	10.3 (3.99)
Sex: Female, Male (Count of Participants)
Female	24 44.4%
Male	30 55.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	4 7.4%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 1.9%
White	46 85.2%
More than one race	0 0%
Unknown or Not Reported	3 5.6%
Region of Enrollment (Number) [Number]
Canada	11 20.4%
Belgium	2 3.7%
United States	32 59.3%
Italy	5 9.3%
Germany	4 7.4%

Outcome Measures

1. Primary Outcome

Title	Change From Screening in Serum Albumin Levels at Week 4
Description	Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 4 were reported.
Time Frame	Screening, Week 4

Outcome Measure Data

Analysis Population Description

Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Calcitriol 3 mcg/g
Arm/Group Description	Participants received calcitriol 3 mcg/g ointment applied twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
Measure Participants	48
Mean (Standard Deviation) [gram per liter (g/L)]	-1.0 (2.28)

2. Primary Outcome

Title	Change From Screening in Serum Albumin Levels at Week 8
Description	Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 8 were reported.
Time Frame	Screening, Week 8

Outcome Measure Data

Analysis Population Description

Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Calcitriol 3 mcg/g
Arm/Group Description	Participants received calcitriol 3 mcg/g ointment applied twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
Measure Participants	30
Mean (Standard Deviation) [g/L]	-1.0 (2.09)

3. Primary Outcome

Title	Change From Screening in Serum Albumin Levels at Week 12
Description	Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 12 were reported.
Time Frame	Screening, Week 12

Outcome Measure Data

Analysis Population Description

Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Calcitriol 3 mcg/g
Arm/Group Description	Participants received calcitriol 3 mcg/g ointment applied twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
Measure Participants	48
Mean (Standard Deviation) [g/L]	-0.8 (2.03)

4. Primary Outcome

Title	Change From Screening in Serum Albumin Levels at Week 20
Description	Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 20 were reported.
Time Frame	Screening, Week 20

Outcome Measure Data

Analysis Population Description

Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Calcitriol 3 mcg/g
Arm/Group Description	Participants received calcitriol 3 mcg/g ointment applied twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
Measure Participants	28
Mean (Standard Deviation) [g/L]	-1.1 (2.10)

5. Primary Outcome

Title	Change From Screening in Serum Albumin Levels at Week 26
Description	Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 26 were reported.
Time Frame	Screening, Week 26

Outcome Measure Data

Analysis Population Description

Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Calcitriol 3 mcg/g
Arm/Group Description	Participants received calcitriol 3 mcg/g ointment applied twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
Measure Participants	40
Mean (Standard Deviation) [g/L]	-0.8 (2.09)

6. Primary Outcome

Title	Change From Screening in Serum Albumin Levels at Week 30 (Follow-up)
Description	Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 30 were reported.
Time Frame	Screening, Week 30 (Follow-up)

Outcome Measure Data

Analysis Population Description

Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Calcitriol 3 mcg/g
Arm/Group Description	Participants received calcitriol 3 mcg/g ointment applied twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
Measure Participants	16
Mean (Standard Deviation) [g/L]	-0.2 (2.95)

7. Primary Outcome

Title	Change From Screening in Urine Calcium/Creatinine Ratio at Week 12
Description	Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 12 were reported.
Time Frame	Screening, Week 12

Outcome Measure Data

Analysis Population Description

Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Calcitriol 3 mcg/g
Arm/Group Description	Participants received calcitriol 3 mcg/g ointment applied twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
Measure Participants	48
Mean (Standard Deviation) [Ratio]	-0.0164 (0.14340)

8. Primary Outcome

Title	Change From Screening in Urine Calcium/Creatinine Ratio at Week 26
Description	Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 26 were reported.
Time Frame	Screening, Week 26

Outcome Measure Data

Analysis Population Description

Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Calcitriol 3 mcg/g
Arm/Group Description	Participants received calcitriol 3 mcg/g ointment applied twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
Measure Participants	38
Mean (Standard Deviation) [Ratio]	0.0456 (0.15588)

9. Primary Outcome

Title	Change From Screening in Urine Calcium/Creatinine Ratio at Week 30 (Follow-up)
Description	Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 30 were reported.
Time Frame	Screening, Week 30 (Follow-up)

Outcome Measure Data

Analysis Population Description

Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Calcitriol 3 mcg/g
Arm/Group Description	Participants received calcitriol 3 mcg/g ointment applied twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
Measure Participants	12
Mean (Standard Deviation) [Ratio]	0.0715 (0.14333)

10. Primary Outcome

Title	Change From Screening in Serum Phosphate Levels at Week 4
Description	Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 4 were reported.
Time Frame	Screening, Week 4

Outcome Measure Data

Analysis Population Description

Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Calcitriol 3 mcg/g
Arm/Group Description	Participants received calcitriol 3 mcg/g ointment applied twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
Measure Participants	48
Mean (Standard Deviation) [mmol/L]	0.0334 (0.17093)

11. Primary Outcome

Title	Change From Screening in Serum Phosphate Levels at Week 12
Description	Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 12 were reported.
Time Frame	Screening, Week 12

Outcome Measure Data

Analysis Population Description

Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Calcitriol 3 mcg/g
Arm/Group Description	Participants received calcitriol 3 mcg/g ointment applied twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
Measure Participants	48
Mean (Standard Deviation) [mmol/L]	0.0237 (0.17996)

12. Primary Outcome

Title	Change From Screening in Serum Phosphate Levels at Week 20
Description	Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 20 were reported.
Time Frame	Screening, Week 20

Outcome Measure Data

Analysis Population Description

Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Calcitriol 3 mcg/g
Arm/Group Description	Participants received calcitriol 3 mcg/g ointment twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks.Participants were further followed up for 4 weeks.
Measure Participants	28
Mean (Standard Deviation) [mmol/L]	0.0079 (0.19925)

13. Primary Outcome

Title	Change From Screening in Serum Phosphate Levels at Week 26
Description	Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 26 were reported.
Time Frame	Screening, Week 26

Outcome Measure Data

Analysis Population Description

Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Calcitriol 3 mcg/g
Arm/Group Description	Participants received calcitriol 3 mcg/g ointment twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks.Participants were further followed up for 4 weeks.
Measure Participants	40
Mean (Standard Deviation) [mmol/L]	0.0091 (0.21262)

14. Primary Outcome

Title	Change From Screening in Serum Phosphate Levels at Week 30 (Follow-up)
Description	Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 30 were reported.
Time Frame	Screening, Week 30 (Follow-up)

Outcome Measure Data

Analysis Population Description

Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Calcitriol 3 mcg/g
Arm/Group Description	Participants received calcitriol 3 mcg/g ointment twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
Measure Participants	16
Mean (Standard Deviation) [mmol/L]	0.0145 (0.18727)

15. Primary Outcome

Title	Change From Screening in Serum Parathyroid Hormone (PTH) Levels at Week 4
Description	Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 4 were reported.
Time Frame	Screening, Week 4

Outcome Measure Data

Analysis Population Description

Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Calcitriol 3 mcg/g
Arm/Group Description	Participants received calcitriol 3 mcg/g ointment twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
Measure Participants	44
Mean (Standard Deviation) [Picomole per liter (pmol/L)]	0.14 (0.967)

16. Primary Outcome

Title	Change From Screening in Serum Parathyroid Hormone Levels at Week 8
Description	Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 8 were reported.
Time Frame	Screening, Week 8

Outcome Measure Data

Analysis Population Description

Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Calcitriol 3 mcg/g
Arm/Group Description	Participants received calcitriol 3 mcg/g ointment twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
Measure Participants	31
Mean (Standard Deviation) [pmol/L]	0.09 (1.451)

17. Primary Outcome

Title	Change From Screening in Serum Parathyroid Hormone Levels at Week 12
Description	Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 12 were reported.
Time Frame	Screening, Week 12

Outcome Measure Data

Analysis Population Description

Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Calcitriol 3 mcg/g
Arm/Group Description	Participants received calcitriol 3 mcg/g ointment twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
Measure Participants	48
Mean (Standard Deviation) [pmol/L]	0.04 (1.400)

18. Primary Outcome

Title	Change From Screening in Serum Parathyroid Hormone Levels at Week 20
Description	Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 20 were reported.
Time Frame	Screening, Week 20

Outcome Measure Data

Analysis Population Description

Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Calcitriol 3 mcg/g
Arm/Group Description	Participants received calcitriol 3 mcg/g ointment twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
Measure Participants	28
Mean (Standard Deviation) [pmol/L]	0.17 (1.152)

19. Primary Outcome

Title	Change From Screening in Serum Parathyroid Hormone Levels at Week 26
Description	Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 26 were reported.
Time Frame	Screening, Week 26

Outcome Measure Data

Analysis Population Description

Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Calcitriol 3 mcg/g
Arm/Group Description	Participants received calcitriol 3 mcg/g ointment twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
Measure Participants	40
Mean (Standard Deviation) [pmol/L]	-0.07 (1.744)

20. Primary Outcome

Title	Change From Screening in Serum Parathyroid Hormone Levels at Week 30 (Follow-up)
Description	Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 30 were reported.
Time Frame	Screening, Week 30 (Follow-up)

Outcome Measure Data

Analysis Population Description

Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Calcitriol 3 mcg/g
Arm/Group Description	Participants received calcitriol 3 mcg/g ointment twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
Measure Participants	18
Mean (Standard Deviation) [pmol/L]	0.37 (1.796)

21. Primary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Description	An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with an onset date on or after the first application of the study drug.
Time Frame	Up to Week 30

Outcome Measure Data

Analysis Population Description

Safety population included as all the participants who have applied the study drug at least once.

Arm/Group Title	Calcitriol 3 mcg/g
Arm/Group Description	Participants received calcitriol 3 mcg/g ointment twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
Measure Participants	54
Count of Participants [Participants]	20 37%

22. Secondary Outcome

Title	Number of Participants With Investigator's Global Assessment of Disease Severity (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Each Visit
Description	The IGA is a 0 to 4 point scale. Where, 0 = clear (no signs of psoriasis except for residual hypopigmentation/hyperpigmentation); 1 = almost clear (just perceptible erythema, no induration, and no scaling); 2 = mild (mild erythema, no induration, and mild or no scaling); 3 = moderate (moderate erythema, mild induration, and mild or no scaling); 4 = severe (severe erythema, moderate to severe induration, and scaling of any degree).
Time Frame	Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)

Outcome Measure Data

Analysis Population Description

Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable this outcome measure and 'n' (number of participants analyzed) signifies number of participants evaluable for each time point.

Arm/Group Title	Calcitriol 3 mcg/g
Arm/Group Description	Participants received calcitriol 3 mcg/g ointment twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
Measure Participants	51
Week 4	3 5.6%
Week 8	5 9.3%
Week 12	15 27.8%
Week 20	14 25.9%
Week 26	19 35.2%
Week 30	17 31.5%

23. Secondary Outcome

Title	Change From Baseline in Pruritus Score at Each Visit
Description	Pruritus was scored on a 0 to 4 point scale. Where, 0 = none (no-itching); 1 = mild (slight itching, not really bothersome); 2 = moderate (definite itching that is somewhat bothersome without loss of sleep); 3 = severe (intense itching that has caused pronounced discomfort, night rest interrupted); 4 = very severe (very severe itching that has caused pronounced discomfort during the night and daily activities). Positive change from baseline indicate worsening of indication.
Time Frame	Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)

Outcome Measure Data

Analysis Population Description

Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable this outcome measure and 'n' (number of participants analyzed) signifies number of participants evaluable for each time point.

Arm/Group Title	Calcitriol 3 mcg/g
Arm/Group Description	Participants received calcitriol 3 mcg/g ointment twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
Measure Participants	51
Week 4	-0.6 (0.85)
Week 8	-0.7 (0.64)
Week 12	-0.7 (0.88)
Week 20	-0.7 (0.96)
Week 26	-0.9 (0.98)
Week 30	-0.8 (1.05)

24. Secondary Outcome

Title	Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit
Description	Percent BSA was calculated by modified rules of nines (pediatric participants). Estimate were made from the following for a child up to the age of one year: head and neck total for front and back - 18%; thorax and abdomen-front -18%; thorax and abdomen-back - 18%; each upper limb total for front and back - 9%; each lower limb total for front and back - 14%. For over the age of one year, the relative percentage of BSA changes as follows: the head decreases by 1% per year and the lower limbs increase by 0.5% per year. By the age of ten years, the relative proportions assume the values for adult BSA as follows: perineum becomes 1%; each lower limb becomes a total of 18% front and back; head and neck become 9% total for front and back.
Time Frame	Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)

Outcome Measure Data

Analysis Population Description

Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable this outcome measure and 'n' (number of participants analyzed) signifies number of participants evaluable for each time point.

Arm/Group Title	Calcitriol 3 mcg/g
Arm/Group Description	Participants received calcitriol 3 mcg/g ointment twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
Measure Participants	51
Week 4	-1.3 (2.85)
Week 8	-2.5 (4.03)
Week 12	-3.4 (4.11)
Week 20	-4.4 (4.61)
Week 26	-3.9 (4.52)
Week 30	-4.7 (5.91)

Adverse Events

Time Frame	From start of treatment up to follow up (30 weeks)
Arm/Group Title	Calcitriol 3 mcg/g
Arm/Group Description	Participants received calcitriol 3 mcg/g ointment twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
All Cause Mortality
	Calcitriol 3 mcg/g
	Affected / at Risk (%)	# Events
Total	0/54 (0%)
Serious Adverse Events
	Calcitriol 3 mcg/g
	Affected / at Risk (%)	# Events
Total	0/54 (0%)
Other (Not Including Serious) Adverse Events
	Calcitriol 3 mcg/g
	Affected / at Risk (%)	# Events
Total	9/54 (16.7%)
Infections and infestations
Nasopharyngitis	6/54 (11.1%)
Skin and subcutaneous tissue disorders
Skin Burning Sensation	3/54 (5.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.